Flagyl film-coated tablets 250 mg No. 20

Flagyl

Flagyl ®

(lat.
Flagil
®) is an antibacterial antiprotozoal drug. The active ingredient is metronidazole.

Dosage forms of flagyl

Flagyl is available in the following dosage forms:

• film-coated tablets containing 250 mg metronidazole
• vaginal suppositories containing 500 mg of metronidazole
• solution for infusion in 100 ml bottles containing 500 mg of metronidazole in a bottle (or 5 mg in 1 ml of solution)

Flagyl activity against pathogenic microorganisms

Flagyl is active against many pathogenic microbes, including:

• protozoa: Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp.
• bacteria: Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Parabacteroides distasonis, Fusobacterium spp., Veillonella spp., Prevotella bivia, Prevotella buccae, Prevotella disiens, Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococ cus spp., Gardnerella vaginalis

The following are resistant to Flagyl: Mobiluncus spp
.,
Propionibacterium acnes, Actinomyces spp
.

Indications for use of flagyl

• infections caused by protozoa:
• trichomoniasis
• giardiasis
• amoebiasis
• amoebic liver abscess

• peritonitis
• abscesses of the abdominal cavity and liver
• endometritis
• abscesses of the ovaries and fallopian tubes
• postoperative complications
• pneumonia, pleural empyema, lung abscess
• meningitis, brain abscess
• skin infections
• bone infections
• sepsis
• endocarditis

• on the colon
• during appendectomy
• during gynecological operations

Flagyl for eradication of Helicobacter pylori

Flagyl is sometimes prescribed as one of the antibiotics as part of complex therapy for the eradication of Helicobacter pylori
.
Flagyl is not used in the eradication of Helicobacter pylori
outside of special regimens, without drugs that reduce gastric acidity.
Flagyl is also not used in any form for the treatment of gastric and duodenal ulcers and gastritis in the absence of Helicobacter pylori in the patient.
According to the Maastricht Agreements, the active substance of Flagyl, metronidazole, is recommended as one of the antibiotics for the eradication of
Helicobacter pylori.
However, in Russia, due to the very wide and not always correct use of metronidazole, the level of resistance to metronidazole is almost twice as high as the European average: 55.5% in Russia and 25.5% in Europe (Maev I.V., Vyuchnova E.S., Shchekina M.I.).
In Russia, it is recommended to use nifuratel in treatment regimens instead of metronidazole (Shcherbakov P.L.). Also, according to modern Russian Standards for the diagnosis and treatment of acid-dependent and Helicobacter pylori-associated diseases, flagyl is allowed only in one of the “second-line” regimens (used if the patient had unsuccessful treatment of Helicobacter pylori
according to one of the “first-line” regimens): flagyl by 500 mg 3 times a day, bismuth tripotassium dicitrate 120 mg 4 times a day, tetracycline 500 mg 4 times a day and one of the proton pump inhibitors in a standard dosage (omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, esomeprazole 20 mg , rabeprazole 20 mg 2 times a day) for 10–14 days.

Methods of using flagyl and dosage

Flagyl tablets are taken orally without chewing during or after meals or with milk:

• Trichomonas vaginalis
  infection - 250 mg 4 times a day for 5 days or 2 g once or 250 mg 2 times a day for 10 days
• for Entamoeba histolytica
  :
• adults - 750 mg 3 times a day for 5–10 days
• children - 35–50 mg per kg of body weight per day, in three divided doses for 10 days

• children from 2 to 5 years old - 250 mg per day
• children from 6 to 10 years old - daily dose - 375 mg
• patients over 10 years old - 500 mg per day

• children under 12 years of age, including newborns - 7.5 mg flagyl per kg body weight 3 times a day
• patients over 12 years old - 250–500 mg 3 times a day

• children from 0 to 5 years - 5 mg flagyl per kg of body weight every 8 hours for 2 days
• children from 5 to 12 years old - 125 mg every 8 hours for 2 days
• patients over 12 years old - initially 1 g once, then 250 mg 3 times a day

Vaginal suppositories are prescribed for adults. Flagyl therapy lasts no more than 10 days and is repeated no more than 2-3 times a year. The dose and duration of use depends on the disease:

• for trichomonas vaginitis, one suppository per day is used for 7-10 days in combination with taking flagyl tablets orally
• for nonspecific vaginitis and bacterial vaginosis, one vaginal suppository per day for 7 days, if necessary in combination with taking flagyl tablets orally

Use of flagyl during pregnancy and breastfeeding

Flagyl is contraindicated in the first trimester of pregnancy; in the second and third trimesters it should be taken with caution only if the benefit to the pregnant woman outweighs the risk to the unborn child, given that metronidazole crosses the placenta. FDA Fetal Category B. Flagyl (metronidazole) is excreted into human milk, creating concentrations similar to those in plasma. May impart a bitter taste to breast milk. To exclude the effect of Flagyl on the child, breastfeeding while taking Flagyl and for 2 more days after finishing it is not recommended.

general information

According to the pharmacological index, flagyl belongs to the groups “Other synthetic antibacterial agents” and “Medicines for the correction of disorders in alcoholism, toxic and drug addiction”, according to the ATC - to the subgroup “J01XD01 metronidazole” of the group “Imidazole derivatives”, as well as to the subgroup “A01AB17 metronidazole "Group "A01AB Antimicrobials for local treatment of diseases of the oral cavity."
Flagyl has contraindications, side effects and application features; consultation with a specialist is necessary.

Manufacturer

flagila - Sanofi Aventis group, France.

On the website gastroscan.ru in the literature catalog there is a section “Antibiotics used in the treatment of gastrointestinal diseases”, containing articles on the use of antimicrobial agents in the treatment of diseases of the digestive tract.

Some official instructions for the medical use of flagyl

Instructions for medical use of flagyl (in pdf):

• “Instructions for the medical use of the drug Flagyl”, vaginal suppositories, 500 mg of metronidazole (for Kazakhstan, Russian), dated 02/21/2011.
• “Instructions for medical administration of the drug Flagyl”, film-coated tablets containing 250 mg of metronidazole (for Ukraine, Ukrainian), dated 05/13/2009.
• "Flagyl metronidazol tablets", 250 and 500 mg tablets (USA, English), April 2010.
• "Flagyl ER metronidazol extended release tablets", extended release tablets 750 mg (USA, English), September 2010.

Other medicines containing the active ingredient metronidazole

Bacimex, Deflamon, Klion, Metrovagin, Metrogyl, Metroxan, Metrolacare, Metron, Metronidazole, Metronidazole IV Brown, Metronidazole Nycomed, Metronidazole-AKOS, Metronidazole-UBF, Metronidazole tablets 0.25 g, Metronidal, Metroseptol, Orvagil, Rosamet, Rozeks, Siptrogil, Trichopol, Tricho-PIN, Trichobrol, Trichosept, Flagyl, Efloran. Back to section

Flagyl film-coated tablets 250 mg No. 20

Side effects

Gastrointestinal disorders Epigastric
pain, nausea, vomiting, diarrhea.

Inflammation of the oral mucosa (glossitis, stomatitis), taste disturbances (metallic taste in the mouth), decreased appetite, anorexia, dry oral mucosa, constipation.

Pancreatitis (reversible cases).

Change in tongue color/coated tongue (due to overgrowth of fungal microflora).

Immune system disorders

Angioedema, anaphylactic shock.

Nervous system disorders

Peripheral sensory neuropathy.

Headache, cramps, dizziness.

The development of encephalopathy (for example, confusion) and subacute cerebellar syndrome (impaired coordination and synergism of movements, ataxia, dysarthria, gait disturbances, nystagmus and tremor), which are reversed after discontinuation of metronidazole, have been reported.

Aseptic meningitis.

Mental disorders

Psychotic disorders, including confusion, hallucinations.

Depression, insomnia, irritability, increased excitability.

Visual disorders

Transient visual impairments, such as diplopia, myopia, blurred outlines of objects, decreased visual acuity, impaired color perception.

Neuropathy/optic neuritis.

Blood and lymphatic system disorders

Agranulocytosis, leukopenia, neutropenia and thrombocytopenia.

Disorders of the liver and biliary tract

Increased activity of liver enzymes (aspartate aminotransferase (AST) and alanine aminotransferase (ALT), alkaline phosphatase), development of cholestatic or mixed hepatitis and hepatocellular liver damage, sometimes accompanied by jaundice.

Cases of liver failure requiring liver transplantation have been observed in patients treated with metronidazole in combination with other antibiotics.

Skin and subcutaneous tissue disorders

Rash, itching, skin hyperemia, urticaria.

Pustular skin rash.

Stevens-Johnson syndrome, toxic epidermal necrolysis.

Renal and urinary tract disorders

Urine may turn brownish-reddish in color, due to the presence of a water-soluble metabolite of metronidazole in the urine.

Dysuria, polyuria, cystitis, urinary incontinence, candidiasis.

General and administration site disorders

Fever, nasal congestion, arthralgia, weakness.

Laboratory and instrumental data

Flattening of the T wave on the ECG.

Flagyl

Release form, composition and packaging

Powder for the preparation of solution for intravenous administration,

Solution for infusion,

Suspension for oral administration,

White to pale yellow, round, film-coated tablets debossed with “F250” on one side.

• 1 tab. metronidazole 250 mg

Excipients: wheat starch, povidone K30, magnesium stearate, hypromellose, macrogol 20,000.

Clinical and pharmacological group: Antiprotozoal drug with antibacterial activity

Pharmacological action and pharmacokinetics

Flagyl belongs to the family of nitro-5 imidazoles and has a broad spectrum of action against anaerobic microorganisms.

Suppresses the development of protozoa - Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia, Peptostreptococcus, Clostridium sp., Bacteroides sp., Prevotella, Fusobacterium, Veilonella.

When taken orally, Flagyl is quickly and completely absorbed. The half-life is 8-10 hours, the connection with blood proteins is weak and does not exceed 10-20%.

The drug quickly penetrates into tissues (lungs, kidneys, liver, skin, bile, cerebrospinal fluid, saliva, seminal fluid, vaginal secretions), into mother's milk and overcomes the placental barrier.

The drug is excreted 40-70% through the kidneys (about 20% in unchanged form).

In patients with liver failure, the half-life remains unchanged.

Indications

The drug is used for

• amebiasis,
• urogenital trichomoniasis,
• nonspecific vaginitis,
• giardiasis.

Intravenous administration of the drug is indicated for

• treatment of surgical infections,
• caused by sensitive anaerobes,
• to prevent the occurrence of anaerobic infections during surgical interventions,
• as well as in severe forms of intestinal and hepatic amebiasis

Dosage regimen

For amebiasis, 1.5 g per day is used orally for 7 days in three doses (adults) and 30-40 mg/kg per day also in three doses (children). ·

Giardiasis is treated for 5 days - adults are prescribed 750-1000 mg per day, children 2-5 years old receive 250 mg per day, children 5-10 years old - 375 mg per day and children 10-15 years old - 500 mg daily. day.

For trichomoniasis in women (urethritis and vaginitis), Flagyl is prescribed once in a dose of 2 g or as a course of treatment for 10 days: 1 tablet. (250 mg) 2 times a day and 1 vaginal suppository (500 mg) per day.

For trichomoniasis in men (urethritis), Flagyl is prescribed once in a dose of 2 g or as a course of treatment for 10 days, 1 tablet. (250 mg) 2 times a day.

For nonspecific vaginitis, use 500 mg of Flagyl 2 times a day for 7 days.

When treating anaerobic infections, adults are prescribed Flagyl 1-1.5 g per day, children - at the rate of 20-30 mg/kg per day.

Intravenous infusion of the drug is indicated only if it is impossible to take it in any other way or in severe forms of the disease. 100 ml (500 mg) of the drug is administered over 30-60 minutes.

Side effect

In rare cases, nausea, metallic taste in the mouth, anorexia, epigastric pain, vomiting, diarrhea, headache and dizziness, as well as local skin reactions such as urticaria and itching, are observed.

With long-term treatment with large doses, leukopenia and peripheral neuropathies may occur, which always regress when treatment is stopped.

A brownish-reddish color to the urine may occur due to the presence of pigments associated with the metabolism of Flagyl.

Contraindications

• Hypersensitivity to imidazoles.

The use of Flagyl in nursing mothers is not recommended.

Pregnancy and lactation

Data not provided.

special instructions

The combination of Flagyl with disulfiram (Esperal), indirect anticoagulants (warfarin) and non-depolarizing muscle relaxants (vecuronium) is undesirable.

The consumption of alcoholic beverages is contraindicated.

The level of lithium in the blood plasma may increase when Flagyl is taken simultaneously with lithium preparations.

Caution is required when used during pregnancy.

Long-term administration of the drug is preferably carried out under the control of the blood count.

With leukopenia, the possibility of continuing treatment depends on the danger of the infectious process. Treatment should be stopped if ataxia, dizziness, or deterioration of the neurological status of patients occur.

It must be taken into account that metronidazole can immobilize treponemes, which leads to a false positive Nelson test

Overdose

Data not provided.

Drug interactions

Strengthens the effect of indirect anticoagulants, which leads to an increase in the time of prothrombin formation. Similar to disulfiram, it causes ethanol intolerance.

Concomitant use with disulfiram can lead to the development of various neurological symptoms (the interval between prescriptions is at least 2 weeks). Metronidazole for intravenous administration is not recommended to be mixed with other drugs. Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its concentration in the blood serum and an increased risk of side effects.

The simultaneous administration of drugs that stimulate microsomal oxidation enzymes in the liver (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, resulting in a decrease in its plasma concentration.

When taken simultaneously with Li+ drugs, the concentration of the latter in the plasma may increase and the development of symptoms of intoxication.

It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide).

Sulfonamides enhance the antimicrobial effect of metronidazole.

Storage conditions and periods

Store at room temperature.

Shelf life: 5 years

Keep out of the reach of children.

Do not use after expiration date.